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Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133664
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : May 3, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 8, 2014
Results First Submitted Date  ICMJE March 22, 2017
Results First Posted Date  ICMJE May 3, 2017
Last Update Posted Date June 2, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Baseline to 12 weeks ]
    The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.
  • Stroop Color-Word Test [ Time Frame: baseline to 12 weeks ]
    The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word "yellow" may be red, the word "blue" may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.
  • California Verbal Learning Test-II (CVLT-II) [ Time Frame: baseline to 12 weeks ]
    CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of "shopping list" items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome.
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: baseline to 12 weeks ]
    The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Cognitive Test [ Time Frame: 12 weeks ]
Change over 12 weeks in any one of the following cogntivie tests, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word Test, California Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association Test (COWAT).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
Official Title  ICMJE Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
Brief Summary The primary aim is to collect data to determine the correct effect size on the primary outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis that have cognitive dysfunction.
Detailed Description

The study is designed as a randomized, double-blind, placebo-controlled pilot trial. The primary aim of the study is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function over 12-weeks in people with multiple sclerosis that have a baseline score of at least two standard deviations below normative values on any one of four cognitive tests that include, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word Test, California Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association Test (COWAT).

The secondary aim is to determine treatment effects on markers of endothelial inflammation, insulin dysregulation, and mitochondrial dysfunction that may be related to cognitive dysfunction by measuring soluble intercellular adhesion molecule-1 (sICAM-1) levels, homeostasis model of insulin resistance (HOMA-IR), and MRI phosphorus imaging in a subset of study participants. The study will also measure safety by adverse event reports and laboratory measures; plasma fatty acid levels; serum lipoic acid levels.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Cognition
Intervention  ICMJE
  • Drug: lipoic acid and omega-3 fatty acids
    alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid
    Other Names:
    • thiotic acid
    • fish oil
    • fish oil concentrate
  • Drug: Placebo
    placebo lipoic acid and placebo oil
    Other Name: placebo lipoic acid and placebo oil
Study Arms  ICMJE
  • Experimental: lipoic acid and omega-3 fatty acids
    lipoic acid and omega-3 fatty acids
    Intervention: Drug: lipoic acid and omega-3 fatty acids
  • Placebo Comparator: placebo
    placebo oil and placebo lipoic acid
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
53
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • A definite diagnosis of multiple sclerosis (MS) with relapsing remitting or secondary progressive course

    • Age 18 to 65 years, inclusive
    • A score two or more standard deviations below the mean in one or more of the following cognitive tests: PASAT, COWAT, CVLT -II, Stroop
    • Expanded Disability Status Scale (EDSS) 0-7.5, inclusive
    • Suboptimal omega-3 levels (plasma docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA] < 5.0% of total plasma fatty acids)
    • If taking MS disease modifying medications, on stable dose for > 6 months preceding enrollment
    • Able to read and write English

Exclusion Criteria:

  • • Moderate to severe depression (Beck Depression Inventory score > 19)

    • Any significant uncontrolled medical problem including diabetes requiring insulin.
    • MS relapse within the 30 days before screening
    • Abnormalities of coagulation or current use of prescription anticoagulants or antiplatelet agents. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are not excluded.
    • Fish intake of one 6 ounce serving > once a week less than 2 months prior to enrollment
    • Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 2 months prior to enrollment
    • Lipoic Acid supplementation less than 1 month prior to enrollment
    • Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
    • Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
    • Epilepsy or history of seizures.
    • Pregnancy or women not using a reliable form of contraception
    • Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color plates or sustained nystagmus or diplopia on primary gaze
    • Inability to complete the neuropsychological test battery at the screening visit
    • Participation in another intervention study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02133664
Other Study ID Numbers  ICMJE PP2190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lynne Shinto, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE National Multiple Sclerosis Society
Investigators  ICMJE
Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP